Cardiopulmonary Exercise Testing and Oscillometry for the Evaluation of Dyspnea

NCT06554353 | Recruiting FDA Device

• 1 other identifier: STUDY00009729
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine if airway resistance to airflow and pressure, measured by Oscillometry, is associated with abnormal findings on Cardiopulmonary Exercise Testing in subjects who are experiencing shortness of breath.

Conditions

Dyspnea; Breathing, Mouth; Lung Function Decreased; Shortness of Breath

Outcome Measures

Primary Outcomes (1)

• Mean respiratory system resistance and reactance

  The oscillometer will collect an airway impedance measurement which is made up of multiple variables.

  Single measurement, approximately day 1

Study Arms (1)

Subjects with dyspnea referred for Cardiopulmonary Exercise Testing

Subjects with unexplained dyspnea referred for Cardiopulmonary Exercise Testing.

Device: Oscillometer

Interventions

Oscillometer DEVICE

The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).

Also known as: THORASYS tremoFlo C-100 Airwave Oscillometry System

Subjects with dyspnea referred for Cardiopulmonary Exercise Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to fifty (50) human subjects will be recruited from the following University of Rochester locations: Mary Parkes Center for Asthma, Allergy, and Pulmonary Care, the Pulmonary Clinic at Strong Memorial Hospital, and The Pulmonary Clinic at Highland Hospital.

You may qualify if:

• Willingness to perform breathing test
• Must be able to speak and understand English
• Referred for Cardiopulmonary Exercise Testing

You may not qualify if:

• Unable to provide consent or perform oscillometry test

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Highland Hospital

Rochester, New York, 14620, United States

RECRUITING

MeSH Terms

Conditions

Mouth Breathing; Respiratory Insufficiency; Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

PATRICK DONOHUE, MD

CONTACT

716-226-8429; patrick_donohue@urmc.rochester.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: October 29, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 3, 2026

Record last verified: 2025-10

Locations

US (1)